FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC— 510(k) K030593

Substantially Equivalent

X-Cel Contacts, A Walman Co.

FDA 510(k) clearance K030593 for FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC, Substantially Equivalent on 2003-05-30. Applicant: X-Cel Contacts, A Walman Co..

Clearance details

Applicant: X-Cel Contacts, A Walman Co.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2003-02-25
Decision date: 2003-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, US

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Adverse events under product code LPL

product code LPL

Injury: 988
Other: 4
Total: 992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.